Data Integrity in the COVID-19 Era and Beyond — Part II: Key Issues in Data Integrity – Virtual Conference Recording/Transcript
COVID-19 has spread across the globe and, in an effort to quell the pandemic, the FDA responded with guidelines to expedite effective treatments and devices. They’ve set new regulations meant to hasten the development and approval of products that could prevent, diagnose or treat the virus.
These guidelines, along with the Coronavirus Treatment Acceleration Program, Operation Warp Speed and growing public pressure, have rapidly pushed forward the process of finding solutions to this massive health crisis.
But this swift pace hasn’t absolved manufacturers and researchers of their long-held data integrity responsibilities. While the processes may be moving at a quicker pace, these standards remain steadfast.
Do you know how to best use to data to manage your supply chain? Have you determined the ways technological advancements, like AI and blockchain, can improve your success? How will your team will adjust to this “new normal”?
This three-part FDAnews virtual conference has your answers.
In this second portion, we’ll cover how to manage your suppliers during and after this global pandemic. We’ll help you figure out the best ways to keep your suppliers on track and how to use technology to gain greater security in your systems. We’ll also discuss testing and validation requirements, AI and blockchain opportunities, and electronic submission obligations.
Data integrity expert Sue Schniepp will lead conversations and panels around data in the time of COVID-19. She and a group of experts will share tips and examples around managing suppliers, meeting testing and validation requirements, and dealing with digital transformations around the pandemic. The group will examine what data integrity’s “new normal” may look like and share advice on how organizations can leverage technological developments to meeting changing global needs.
Key Virtual Conference Takeaways:
- Managing Suppliers
- Keeping suppliers on track during a global pandemic
- Using technological developments to secure supply chains
- Dealing with problematic suppliers
- Ensuring testing and validation meets good manufacturing practices requirements
- Taking advantage of technological updates
- Adapting to the “new normal” after the pandemic
- Making AI and blockchain work for you
- Complying with electronic submission requirements
- Preparing for post-pandemic digital obligations
Stay with us for the entire three-part virtual conference and we’ll cover:
- Part I — The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic
Purchase as an Encore Presentation. Recorded on Thursday, Aug. 4, 2020
- Data integrity and practices in the age of the COVID-19
- The impacts of COVID-19 on operations and supply chain management
- FDA regulations around data and COVID-19
- Inspection and audit practices, including virtual interactions and best practices
- Part III — The Real-World Costs of Data Integrity
Wednesday, Oct. 28, 2020, 1:30 p.m. – 5:00 p.m. EDT
- Document and Data Creation, Maintenance and Archival: Best Practices
- Creating the data and documents you need to better obtain information for inspection compliance
- Maintaining and preserving documents through the latest technology
- Ensuring the deployment of industry best practices in inspection compliance
- Increasing Productivity through Effective Implementation of Data Integrity Concepts
- Determining which key data integrity concepts will best serve your organization
- Understanding how data integrity adherence can benefit both compliance and productivity
- Finding the lessons COVID-19 is teaching us about data integrity
- Deploying a Solid Risk Management Strategy for Data Integrity
- Applying the ICH Q9 guidance when implementing an effective risk management strategy around data integrity
- Making sure your team has meaningful and effective risk management strategies based on the design, operation and monitoring of systems and controls, along with the risk to patients, process and product
- Finding the unique risk mitigation strategies your team can employ to ensure the integrity of electronic data systems
- Using audit trails as part of a risk management strategy
- Remediating data integrity problems through a risk management strategy
Don’t let data integrity compliance issues jeopardize the effectiveness, safety, and success of your medical products. This virtual conference will give you the tools you need to maintain this crucial element of your process, manage your complicated supply chains, and make advances through technological changes.
Meet Your Facilitator
Sue Schniepp, distinguished fellow at Regulatory Compliance Associates, is a data integrity expert who has served on the board of directors of the Parenteral Drug Association, as the PDA/FDA Joint Regulatory Affairs conference chair, and as chair of the PDA’s Regulatory Affairs/Quality Advisory Board. She has also been a PDA conference presenter and was awarded PDA’s Distinguished Service Award.
Sue Schniepp will be joined by an array of data integrity experts, including policy advisors, regulatory compliance experts, and medical product consultants.
Who Will Benefit
- Pharmaceutical and device manufacturing teams
- CROs and clinical trial sponsors
- Data integrity consultants
- Regulatory, quality, and compliance specialists
- Clinical trial developers
- Clinical study data experts
- Vice presidents of strategic planning
- Medical product attorneys
- Drug and device consultants
Virtual Conference Recording & Transcript Bundle
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Virtual Conference date:
Sept. 23, 2020